The Integral Project Manager sets up and manages a cross-functional team to deliver new products and/or services within defined business requirements of cost, quality & time, in accordance with applicable regulations & company policies & procedures. The Integral Project Manager integrates input from the Functions represented by the Project Team to reach a joint solution which maximizes business value & meets technical objectives. He/she monitors the implementation of the joint solution by the Function & manages project risks. He/she is in charge of high complexity projects. He/she can work in a highly dynamic environment. He/she can work with external parties. He/she has a proven track record in project management and product development in the IVD Industry.
Principal Contributions/Accountabilities & Associated Activities
Manages the project business value within agreed project specifications & objectives.
Ensures (together with Functional Manager) alignment & mutual commitment between the project & functions objectives.
Manages project risk analysis & risk mitigation plans within the project team: initiation, follow-up & reporting.
Leads remaining problem solving with the functions to make shared decisions on technical issues, resource allocation conflict or any deviation vs. project specifications.
Develops cross-functional plans & schedules & controls their implementation.
Manages the project in accordance with applicable regulations & company policies & procedures (Product Realisation Production (PRP) process and applicable design controls).
Manages delivery of project documentation (Design History File/Device Master Records).
Manages phase gating of the project and prepares project business reviews for the Management Team.
Delivers regular updates to the sponsor on costs, timing, quality, scope, business value.
Contributes to the Functional Manager’s performance management of project leaders & team members & specialists.
Assures smooth hand over to (mass) production organisation.
Scope & Resource Accountability
Responsible for project-specific budget (FTE/specific costs), time & quality
Manages a multi-disciplinary project team
Manages high complexity (organizational and/or technical) integral project
Serves as communication conduit
You will be working alongside 2 other project managers who each are responsible for another product within the product line. Your project team will consist of 8 to 12 people depending on the stage the project is in. Furthermore you will be in close contact with the customer who is collaborating on the development of our product.
We are looking for
We are looking for an experienced project manager with experience in the IVD industry. You are a strong communicator that can address issues openly. You have a can do attitude and experience resolving complex issues and establishing clear priorities.
A bachelor or master degree in Biomedical Science, Business Administration or other relevant degree.
At least 5 years of experience in the IVD industry as project manager or NPI manager.
Preferably a track record of bringing (IVD) products to market as PM
Demonstrable experience delivering multi-million projects. Preferably within the medical device industry.
Experience with the delivery of project documentation such as Design History Files and or Device Master Records.
Experience with Quality and Regulatory demands for the medical devices industry.
Excellent communication skills - diplomatic and open communicator who can address tough issues when necessary.
Excellent problem solving skills.
Long term vision – be able to judge the impact on your decisions on your own and other projects.
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